FDA 510(k)

Stryker and Serf hip devices

K-Number: K250989 · 2025-07-25

ApplicantHowmedica Osteonics Corp (Dba Stryker Orthopaedics)

Decision Date2025-07-25

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Stryker and Serf hip devices is a medical device manufactured by Howmedica Osteonics Corp (Dba Stryker Orthopaedics). It received FDA 510(k) clearance on 2025-07-25 under approval number K250989. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker and Serf hip devices?

Stryker and Serf hip devices is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Howmedica Osteonics Corp (Dba Stryker Orthopaedics). The 510(k) number is K250989.

When was Stryker and Serf hip devices approved by the FDA?

Stryker and Serf hip devices received FDA 510(k) clearance on 2025-07-25, under approval number K250989.

What company makes Stryker and Serf hip devices?

Stryker and Serf hip devices is manufactured by Howmedica Osteonics Corp (Dba Stryker Orthopaedics).

What is the FDA product code for Stryker and Serf hip devices?

The FDA product code for Stryker and Serf hip devices is LPH.

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.